FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
146257–146280 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1985
SAFE.N.SURE
K852620 · HIS
Ashai Co. , Ltd.
Obstetrics & Gynecology · 133d
Cleared Oct 31, 1985
INTERPORE 200 POROUS HYDROXYAPATITE
K852975 · DZC
Inrterpore Intl.
Dental · 108d
Cleared Oct 31, 1985
ILEX PROMPT CLINICAL CHEMISTRY ANALYER
K853068 · CEM
Ilex Corp.
Chemistry · 101d
Cleared Oct 31, 1985
PAXIAL
K853116 · IYO
Biophysic Medical, Inc.
Radiology · 98d
Cleared Oct 31, 1985
AUSTENAL MODIFIED ACRYLIC DENTURE RESIN
K853160 · ELM
Austenal Dental, Inc.
Dental · 93d
Cleared Oct 31, 1985
DENTAL CEMENT
K853431 · EBF
Dentsply Intl.
Dental · 77d
Cleared Oct 31, 1985
IRREGULAR CURVE TRACING REVISITION & DOPPLER
K853769 · DXK
Hewlett-Packard Co.
Cardiovascular · 52d
Cleared Oct 31, 1985
DB PRECISION IMPLANT SYSTEM
K853788 · DZE
Driskell Bioengineering
Dental · 51d
Cleared Oct 31, 1985
THROMBO SCREEN SICKLE CELL ASSAY SET
K854079 · GHM
Pacific Hemostasis
Hematology · 24d
Cleared Oct 31, 1985
MICRO-MAT SYSTEM
K854121 · GKJ
Prevo Micro-Mat System
Hematology · 22d
Cleared Oct 31, 1985
POLYCHROME IV STAIN
K854176 · LED
Devetec, Inc.
Pathology · 16d
Cleared Oct 31, 1985
ULTRACLONE 05-100 GUINEA PIG RBC
K854206 · KPO
Earl-Clay Laboratories, Inc.
Pathology · 15d
Cleared Oct 31, 1985
COLUMBIA 5% BLOOD AGAR
K854228 · KZI
R. Kent Richards, Inc.
Microbiology · 13d
Cleared Oct 30, 1985
XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM
K853459 · IXK
Xerox Medical Systems
Radiology · 75d
Cleared Oct 30, 1985
MEDIPART BACTERIA FILTER MP-2615
K853577 · CAH
Medipart Jerry Alexander
General Hospital · 65d
Cleared Oct 29, 1985
BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC.
K844446 · ELW
Pulpdent Corp. of America
Dental · 347d
Cleared Oct 29, 1985
DENTOCULT CULTURE-PADDLE
K851164 · JJJ
Orion Corp.
Microbiology · 221d
Cleared Oct 29, 1985
PEAK FLOWMETERS FOR SPIROMETRY
K851265 · BZH
Solcoor, Inc.
Anesthesiology · 214d
Cleared Oct 29, 1985
DMA OXYGEN MONITOR
K852823 · CCL
Ferguson Medical
Anesthesiology · 120d
Cleared Oct 29, 1985
FREEMAN HIP
K852839 · JDI
Advanced Biosearch Assn.
Orthopedic · 116d
Cleared Oct 29, 1985
MILLAR MIKRO-TIP DOPPLER CATHETER
K853138 · JOP
Millar Instruments, Inc.
Cardiovascular · 95d
Cleared Oct 29, 1985
GT HIP PROSTHESIS FEMORAL COMPONENT
K853169 · JDI
Intermedics Orthopedics
Orthopedic · 91d
Cleared Oct 29, 1985
PLASTIC MOUTH BARRIER HSV-I
K853266 · BYP
Westmark Enterprises, Inc.
Anesthesiology · 85d
Cleared Oct 29, 1985
VISTECH VCTS GLARE TESTER
K853481 · HOX
Vistech Consultants, Inc.
Ophthalmic · 70d